They lead an epochal battle and fight against time, in difficult conditions due to the lockdown that is blocking much of the planet. Isolated as much as possible, researchers from Moderna, the American biotech company (based in Cambridge, Massachusetts, where it was born ten years ago) that first developed an experimental vaccine against Covid-19, face the biggest challenge.
On March 16, the American government through the National Institute of Health (our Institute of Health) started phase 1 of the human RNA vaccine trial, enrolling 45 volunteers, adults in good health, to whom it was administered the vaccine intramuscularly to test its ability to induce an immune reaction against the virus, evaluate the dosages and verify its safety in terms of toxicity and tolerability.
It will take about six to eight weeks to process the data and move on to the next phases, but in Moderna they are cautiously optimistic and everyone works tirelessly speeding up the processes and minimizing the time to get both the approval of the vaccine and its administration to the population .
Head of Moderna's infectious disease research team is Andrea Carfi, Italian by birth and American by adoption, a virus expert: he has been studying them since his postdoctoral period at the Children's Hospital in Boston where he has worked with field scientists. After graduating in chemistry in Pavia and a doctorate in Grenoble, France, he chose the United States and, except for a working spell in Italy, he has lived in Cambridge for eleven years.
It all began on January 10, 2020, when the Chinese authorities shared the genetic code of a new Coronavirus with the scientific community and the ongoing challenge began. Was the danger of the new virus immediately clear to you and the need to operate in a completely different way from the norm?
“The data that came in from China every day was extremely alarming about its spread. But the virus was not entirely unknown. In fact, thanks to previous experience and results obtained in the past on vaccines against other viruses of the same family, such as Sars and Mers, and thanks to the collaboration with the Vrc (Vaccine Research Center, the vaccine research center of the American government ) we got to the vaccine design very quickly. In less than three weeks we started preclinical studies, showing that the vaccine worked in vitro and started experiments in mice. Just forty-two days after the publication of the sequence, we were able to send the vaccine to Nih to begin clinical trials. ”
An exclusive Espresso interview with Andrea Carfi, the scientist in charge of the infectious diseases research team at a US biotech company that is already testing it
How was it possible to achieve these results immediately?
“The use of RNA technology made it possible to go very quickly. RNA contains information that allows cells to express a protein of interest, in this case a virus protein, thus allowing to generate an immune response in the person to whom it is injected. A great credit goes to my colleagues in the Technical Development who have quickly adapted processes that we use for other applications against infectious diseases, to that of vaccines. It was an incredible non-stop tour de force ».
The American health authorities, given the emergency, have allowed us to quickly enter the human clinical trial. How are you doing?
“In this first phase, the goal is to demonstrate that the vaccine is well tolerated and does not cause side effects at increasing doses. It will also be shown that the vaccine is immunogenic and produces the desired effects. This is the initial stage and then the vaccine is tested in a much larger number of people in the following studies. We work towards optimizing every second of time. We evaluate all possible scenarios in order to be ready to proceed very quickly. All while maintaining the safety of the people who participate in clinical trials ».
To complete all the study and test phases of a new vaccine usually takes years, at least four or five. Today we don't have this time. When can you realistically think that the vaccine is available?
“The goal is to start phase 2 by this spring and phase 3 in the fall to approve the vaccine in 2021. But given the emergency, regulatory authorities may perhaps authorize administration exceptionally even before final approval, starting from the autumn of this year, only for doctors, nurses and health workers who risk contact with the virus every day and then to follow the elderly ».
And for others?
“We are working on several fronts, including that of large-scale vaccine production, we are talking about millions of doses to be produced and administered, after final approval.”
How much can the vaccine cost in terms of research and testing?
«Developing a vaccine is certainly very expensive, several stages are needed for clinical trials and thousands of people need to be involved in order to demonstrate the safety and efficacy of the vaccine. Typically we talk about several hundred million dollars.
Huge sums, but all in all nothing compared to the first and foremost human and then economic losses that the whole world is enduring.
“The impact of the pandemic is there for all to see, first of all in terms of suffering, of lost human lives, of stress for health systems. But there are other aspects besides the health ones, the costs are enormous from all points of view. Therapeutic approaches can certainly alleviate the situation if identified in time. But the history of infectious diseases has shown that vaccines are the most effective and safest approach to defeat the virus, stop the pandemic and avoid falling back into the same situation in the future. What has happened in Italy, and what is happening in many other countries these days, teaches us that we must work and invest in order to be prepared as much as possible for new epidemics, we need a great effort to prevent and control them and we need to put systems in place able to react and respond quickly to the emergency. Today we are learning, from good practices and also from mistakes, but we must absolutely avoid finding ourselves in a similar situation again in the future ».
Given the spread of the pandemic, is it reasonable to think that although the curve of infection and death will decrease thanks to measures of isolation and social distance, the only way to return to normal will be the vaccine?
«It is always difficult to predict the future, science tries but it is not able to do it exactly. I personally believe that the vaccine is the most likely solution to the present problem and future risks. I'm not just talking about the vaccine we are working on, there will also be others who will be able to bring their contribution to get out of this nightmare. The measures of containment and social isolation, if implemented rigorously and in the right timeframes, can be as successful as happened in China or South Korea and I hope also in Italy, but there is a risk that the virus will return and only a vaccine used on a large scale can permanently block it. ”